20-11-PTSD-DT

Posttraumatic Stress Disorder-Drug Treatment (PTSD-DT) Adaptive Platform Trial (APT)

This program aims to support the development and maintenance of clinical trial infrastructure for the simultaneous and sequential testing of drug interventions to treat post-traumatic stress disorder (PTSD) in an adaptive platform trial (APT) design. The PTSD APT will test a minimum of two drugs versus a placebo in a platform design, which allows for replacement of drugs based on pre-defined rules for success or futility.  Adaptive platform trials are often based on Bayesian statistical models with multiple features that improve trial efficiency and decision-making.  The requirement for this program includes three focus areas.

 

  • Focus Area #1 (Statistical Modeling): Trial design, simulation, initiation, and execution, including drafting of key documents (e.g., statistical sections of Master Protocol, Statistical Analysis Plan, Operational Plan).
  • Focus Area #2 (Drug Selection): Operationalization and execution of a drug selection process for initial and continual selection of interventions to be tested in the APT.
  • Focus Area #3 (Clinical and Clinical Operations): Completion of the APT design, development of clinical trial infrastructure, and execution of the APT.

 

The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (20-11-PTSD-DT).

 

 

PPD PTSD APT Proposal Focus Areas 1, 2, 3

Project Team: PPD Development

Award Amount: $5.21M

Project Duration: 62 months

Project Objective: This project aims to support the development and maintenance of clinical trial infrastructure for the simultaneous and sequential testing of drug interventions to treat post-traumatic stress disorder (PTSD) in an adaptive platform trial (APT) design. An APT provides a unified infrastructure to make the clinical trial faster, less expensive, and more efficient.

 

 

 

Berry Consultants Proposal for MTEC-20-11-PTSD-DT

Project Team: Berry Consultants

Award Amount: $0.25M

Project Duration: 59 months

Project Objective: Berry Consultants proposes the design and execution of an adaptive platform trial investigating at least two therapies for the treatment of PTSD. Adaptive platform trials, a type of master protocol, are ideally suited for the exploration of multiple therapies in difficult to treat indications. Their central advantage is economy of scale. Instead of conducting multiple separate experiments, duplicating work in protocol development, site management, data base construction, statistical support, regulatory affairs, etc., a master protocol allows for the common elements of these trials to be created commonly for use by all the novel therapies under investigation. This significantly reduces the operational cost of investigating the therapies. While typically requiring more work to set up and start the first therapy, after a master protocol is running additional therapies typically may be added quickly by including a new “appendix” to the master protocol describing only the specific aspects of the new therapy.

 

 

 

MTEC Drug Prioritization/Selection for the PTSD APT: Focus Area #2

Project Team: Informa Business Intelligence

Award Amount: $0.36M

Project Duration: 51 months

Project Objective: The objective of this project is to outline, plan, and execute a drug selection process for initial and continual selection of interventions to be tested in the PTSD APT. The Informa team will gather efficacy and safety data from public and proprietary databases for drugs tested in PTSD and related conditions, which will be prioritized for testing in the APT based on DOD-defined criteria. The deliverable will provide a centralized repository of clinical trial results for key marketed and pipeline therapies in the PTSD space. In addition, the drug and clinical trial list will be filtered by MOA before being scored and weighted within each MOA based on DOD-defined criteria. The final output will be filtered to prioritize MOAs with the highest weight of evidence from trial-level results, and within each MOA, therapies will be filtered for to prioritize drugs with the highest level of evidence from clinical trial data.